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    • Regulatory Affairs

    Regulatory Affairs Courses

    Regulatory affairs courses can help you learn how to navigate laws, guidelines, and approval processes that govern healthcare products, medical devices, and pharmaceuticals.

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    Find the Best Regulatory Affairs Course for Your Goals

    • Status: Free Trial
      Free Trial
      N

      Novartis

      Introduction to Good Clinical Practice

      Skills you'll gain: Clinical Research, Clinical Trials, Patient Education And Counseling, Healthcare Ethics, Medical Science and Research, Regulatory Compliance, Medical Privacy, Risk Management

      4.7
      Rating, 4.7 out of 5 stars
      ·
      353 reviews

      Beginner · Course · 1 - 4 Weeks

    • Y

      Yale University

      Introduction to Medical Software

      Skills you'll gain: Clinical Trials, Software Development Life Cycle, Software Quality Assurance, Systems Development, Usability, Software Development, Medical Privacy, Human Computer Interaction, Verification And Validation, Risk Management, Medical Management, User Interface (UI), Health Care Procedure and Regulation, Software Design, Healthcare Industry Knowledge, Regulatory Compliance, Health Technology, Entrepreneurship, Artificial Intelligence and Machine Learning (AI/ML), Cybersecurity

      4.8
      Rating, 4.8 out of 5 stars
      ·
      262 reviews

      Intermediate · Course · 3 - 6 Months

    • Status: Free Trial
      Free Trial
      U

      University of Minnesota

      Healthcare Marketplace

      Skills you'll gain: Competitive Analysis, Payment Systems, Intellectual Property, Health Systems, Healthcare Industry Knowledge, Commercialization, Pharmaceuticals, Leadership Development, Health Care Administration, Product Management, Medical Management, Go To Market Strategy, Regulatory Affairs, Medical Equipment and Technology, Organizational Structure, Market Opportunities, Health Care, Market Analysis, Cost Benefit Analysis, Health Care Procedure and Regulation

      4.5
      Rating, 4.5 out of 5 stars
      ·
      1.5K reviews

      Beginner · Specialization · 3 - 6 Months

    • U

      University of London

      Global Diplomacy – Diplomacy in the Modern World

      Skills you'll gain: Diplomacy, International Relations, World History, Political Sciences, Policy Analysis, Public Affairs, Mediation, Interpersonal Communications

      4.7
      Rating, 4.7 out of 5 stars
      ·
      5.3K reviews

      Mixed · Course · 1 - 3 Months

    • Status: Free Trial
      Free Trial
      U

      University of Pennsylvania

      Intellectual Property in the Healthcare Industry

      Skills you'll gain: Intellectual Property, Healthcare Industry Knowledge, Pharmaceuticals, Health Care Procedure and Regulation, Regulation and Legal Compliance, Legal Strategy, Medical Privacy, Health Policy, Medical Science and Research, Branding, Economics, Policy Analysis

      4.8
      Rating, 4.8 out of 5 stars
      ·
      139 reviews

      Beginner · Course · 1 - 4 Weeks

    • Status: Free Trial
      Free Trial
      U

      University of Pennsylvania

      Privacy Law and HIPAA

      Skills you'll gain: Medical Privacy, General Data Protection Regulation (GDPR), Personally Identifiable Information, Law, Regulation, and Compliance, Information Privacy, Regulatory Compliance, Compliance Management, Health Care Procedure and Regulation, Data Governance, Data Security, Security Controls, Incident Response, Risk Analysis

      4.6
      Rating, 4.6 out of 5 stars
      ·
      158 reviews

      Mixed · Course · 1 - 4 Weeks

    • U

      University of Manchester

      Industrial Biotechnology

      Skills you'll gain: Process Engineering, Molecular Biology, Chemical Engineering, Life Sciences, Biochemistry, Bioinformatics, Biology, Pharmaceuticals, Environmental Engineering, Manufacturing Processes, Process Development, Microbiology

      4.7
      Rating, 4.7 out of 5 stars
      ·
      3.5K reviews

      Beginner · Course · 1 - 3 Months

    • Status: Free Trial
      Free Trial
      U

      University of California San Diego

      Drug Discovery

      Skills you'll gain: Pharmaceuticals, Pharmacology, Clinical Research, Bioinformatics, New Product Development, Medical Science and Research, Regulatory Affairs, Molecular Biology, Market Opportunities, Innovation, Chemistry

      4.6
      Rating, 4.6 out of 5 stars
      ·
      3.9K reviews

      Beginner · Course · 1 - 3 Months

    • Status: Free Trial
      Free Trial
      U

      University of California San Diego

      Drug Commercialization

      Skills you'll gain: Commercialization, Pharmacotherapy, Pharmacology, Intellectual Property, Clinical Trials, Portfolio Management, Strategic Partnership, Regulatory Affairs, Product Marketing, Go To Market Strategy, Business Strategy, Marketing Strategies, Market Dynamics, Business Development

      4.7
      Rating, 4.7 out of 5 stars
      ·
      1.3K reviews

      Beginner · Course · 1 - 3 Months

    • K

      Knowledge Accelerators

      The ABC's of GDPR: Protecting Privacy in an Online World

      Skills you'll gain: General Data Protection Regulation (GDPR), Information Privacy, Personally Identifiable Information, Regulatory Compliance, Compliance Management, Data Security, Governance, Data Governance, Regulatory Requirements, Legal Risk, Data Collection

      4.9
      Rating, 4.9 out of 5 stars
      ·
      53 reviews

      Beginner · Course · 1 - 4 Weeks

    • Status: Free
      Free
      P

      Princeton University

      Bitcoin and Cryptocurrency Technologies

      Skills you'll gain: Blockchain, Cryptography, Encryption, Payment Systems, FinTech, Application Security, Digital Assets, Network Protocols, Data Mining, Transaction Processing, Data Storage, Distributed Computing, Emerging Technologies, Scripting, Public Affairs, Market Dynamics

      4.6
      Rating, 4.6 out of 5 stars
      ·
      3K reviews

      Mixed · Course · 1 - 3 Months

    • Status: New
      New
      C

      Coursera Instructor Network

      GenAI for Fraud Detection and Compliance

      Skills you'll gain: Generative AI, Law, Regulation, and Compliance, Regulatory Requirements, Compliance Management, Compliance Reporting, Governance, Business Risk Management, Governance Risk Management and Compliance, Risk Management, Financial Regulation, Anomaly Detection, Compliance Auditing, Data Governance, Artificial Intelligence, Large Language Modeling, Threat Detection, Advanced Analytics

      4.7
      Rating, 4.7 out of 5 stars
      ·
      26 reviews

      Intermediate · Course · 1 - 4 Weeks

    1234…53

    In summary, here are 10 of our most popular regulatory affairs courses

    • Introduction to Good Clinical Practice: Novartis
    • Introduction to Medical Software: Yale University
    • Healthcare Marketplace: University of Minnesota
    • Global Diplomacy – Diplomacy in the Modern World: University of London
    • Intellectual Property in the Healthcare Industry: University of Pennsylvania
    • Privacy Law and HIPAA: University of Pennsylvania
    • Industrial Biotechnology: University of Manchester
    • Drug Discovery : University of California San Diego
    • Drug Commercialization : University of California San Diego
    • The ABC's of GDPR: Protecting Privacy in an Online World : Knowledge Accelerators

    Why Learn Regulatory Affairs?

    Regulatory affairs ensures that products like medications, medical devices, and biologics meet safety, efficacy, and compliance standards before reaching the market. It plays a critical role in aligning innovation with public health regulations. Learning regulatory affairs can help you understand approval pathways, manage documentation, and support global compliance in health-related industries.

    Frequently Asked Questions about Regulatory Affairs

    Popular options include Regulatory Compliance from the University of Pennsylvania, and Quality Control and Regulatory in Cosmetic Science from Olay, which touch on regulatory pathways. While Coursera doesn’t offer a dedicated “regulatory affairs” specialization, many courses integrate essential compliance and policy concepts.‎

    Yes. Many courses relevant to regulatory affairs offer a free audit option, allowing learners to access video lectures and reading materials at no cost. To complete assignments or earn a certificate, you’ll need to upgrade or apply for financial aid.‎

    You’ll learn about the approval process for pharmaceuticals, medical devices, or food products; how to navigate regional and global regulations; and how to ensure product safety and efficacy. Courses may also introduce clinical trials, labeling, and post-market surveillance.‎

    Not necessarily. Many courses are designed for general learners and those exploring career options in regulatory affairs. For more technical courses—especially those that touch on drug development or clinical trials—some prior knowledge of biology or health sciences can be helpful.‎

    Yes. Regulatory affairs professionals are essential in ensuring that products meet compliance standards and reach the market safely. Coursera courses can help you build foundational knowledge, prepare for certification, and understand the global regulatory landscape.‎

    This FAQ content has been made available for informational purposes only. Learners are advised to conduct additional research to ensure that courses and other credentials pursued meet their personal, professional, and financial goals.

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